This rapid test is an immuno-chromatographic test, using colloidal
gold immunoassay method, to detect the antibody against FMD virus
in whole blood, serum. After adding sample, the sample move along
with the colloidal gold labeling FMD antigen, is there is FMD
antibody in the sample, it combines with antigen on T line and show
wine-red color; if there is no FMD antibody, then no color
reaction.

Components

1

FMD Ab test card

50 pieces

2

Dropper

50 pieces

3

Antibody titers Colorimetric card

1 piece

4

Disposable gloves

1 pair

5

Manual

1 piece

Test Procedure

1) Collect whole blood, separate serum (centrifuge at 2000-3000
r/min for 5~15min or separate out naturally at 4℃ overnight), or
take whole blood with anticoagulants as sample. Take whole blood
without anticoagulants as sample is also OK, but must test it
immediately.

2) Open the package, take out test card, put it on clean, flat
desk.

3) Use dropper to absorb the sample, adding 3 drops sample into “S”
mark well slowly drop by drop.

4) Judge the result in 10-20min, it is invalid beyond 20min.

INTERPRETATION OF RESULTS

Positive: control line and test line are both seen wine red, the more the
antibody exist, the thicker the color appear;

2) Weak positive: control line and test line are both seen wine red, but the color
of test line is very light;

3) Negative: only control line is seen wine red;

4) Invalidation: control line isn’t seen wine red.

QUALITY CONTROL

A procedural control is included in the test. A line appearing in
the control region

Control standards are not supplied with this kit. However, it is
recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify
proper test performance.

Notice

1) Do not use test card out of date and bad package;

2) Do not use pure water, running water and normalsaline as negative control;

3) Store at room temperature (< 30℃) is OK. If store in cool,
need return to room temperature firstly, then open package, avoid
moisture. Use the test card as soon as possible after open the
package.

4) Do not touch the white membrane surface in the middle of test
card.

5) To ensure the test quality, take fresh, unpolluted sample. If
there is a lot of blood lipids, it will affect the result, so after
centrifuge, take serum to test, avoid fat. If the blood or serum is
sticky or not enough, use normalsaline to dilute at same dilution factor to dilute, then to test.

6) If the serum can not be tested immediately, store at 4℃ for
short time (in 48hours), store at below -20℃ for long-tern storage.

7) Whole blood without anticoagulants should be tested immediately;
if already exist part of cruor, separate serum to test. The whole
blood with anticoagulants should be tested in 24hours, do not
frozen. Freezing and thawing causes hemolysis of red blood cells
rupture, seriously affect the test results.

8) When dropping sample, keep head of dropper and “S” well at 1cm
to ensure adding sample accurately. If too close, can cause small
droplet volume caused by drips judgment error or is not allowed to
join the sample size, influence the test results.

9) Avoid bubble when adding sample, the sample quantity should be
controlled at about 100ul (about 3 drops). Too much sample would
not increase sensitivity. In particular, the whole blood of
excessive have made erythrocyte sedimentation in "show hole" place,
causing membrane chromatography is so deep into the red background,
seriously affect the results.

10) The antibody level is only related to darkness of T line, no
relation with C line. Only the C line is clean to see, it means the
test is valid.

11) Treat the test card and sample at pollutant according to local
regulations.

performance characteristics

The specimen correlation study was performed on 283 Blood
specimens. 22 positive urine specimens and 218 negative urine
specimens were confirmed by GC/MS.

Established in 2009, Orient New Life Medical Co., Ltd., is
specialized in high-tech biological diagnostic test development,
research and production, as well as high-tech medical device
development, research and production. New Life has built up two
production base, which produce biological diagnostic test and
endoscopic medical device respectively. Our products ranged in the
following specialties: drug of abuse tests, fertility tests,
infectious diseases tests, sexual transmitted diseases tests, tumor
markers tests, cardiac markers tests, veterinary tests, and
surgical stapler series.

Company's core technical team with more than 35 employees，3 doctors
and 25 masters. They have many years of famous universities in the
United States and pharmaceutical companies engaged in the project
research and development, production and marketing, business
management experience.Company owns hundreds of grade purification
workshop and all level of quality checkout room, equipped with
various production and testing equipment.